Effect of Total Compression Time and Rate (Slope) on Incidence of Symptomatic ETD and MEB: A Phase II Prospective Study.

Completed · Not applicable

Conditions studied: Eustachian Tube Dysfunction, Middle Ear Barotrauma, Middle Ear Disease, Middle Ear; Injury, Pressure Injury, Ear Barotrauma

In brief

Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. The investigators randomly assigned patient-treatment group exposures to four different time interval and rate (slope) of compression. These total time intervals of compression and rates (slopes) of compression are identical to those used in the Phase I trial. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the 4 compression schedules, similar to ther Phase I trial will be recorded. Patients who are symptomatic and require compression stops (as in the Phase I trial) using a United States Navy Treatment Table 9 (USN-TTN9) during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be analyzed. Analysis using descriptive and inferential statistics will be applied to the patients requiring first stops in the 4 compression profiles. This Phase II study increases the sample size of treatments and they will be combined with the total number of treatments used in the original phase I study. This will increase power to facilitate detailed descriptive analysis and to determine if the findings are robust in the phase I study.

Key facts

Study ID
NCT04776967
Run by
Northwell Health
People needed
300
Starts
2014-09-08
Expected to finish
2021-02-28
Last updated by the study team
2021-08-19

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

Where it is running

Full record on ClinicalTrials.gov

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